表面活性剂及高分子物质对呋喃西林溶解行为及溶液稳定性的影响

Effects of Surfactants and Polymers on Solubilization and Solution Stability of Furacilin

目的:探讨不同增溶物质和高分子物质对呋喃西林溶解行为及溶液稳定性的影响。方法:选择表面活性剂如十二烷基硫酸钠(SDS)、吐温80、泊洛沙姆407,及高分子物质如聚维酮K30(PVPK30)、系列羟丙甲基纤维素(HPMC K100、HPMC50、HPMC 30),配制成系列浓度的溶液,采用紫外分光光度法测定呋喃西林在其中的最大溶解度。同时,考察高温灭菌和低温冷藏后各溶液的稳定性。结果:在考察的表面活性剂或高分子物质浓度0.1～10.0 mg·ml^(-1)范围内,呋喃西林被增溶的最大饱和溶解度分别为0.245 ng·ml^(-1)(C_(吐温80)=5 mg·ml^(-1)),0.256 mg·ml^(-1)(C_(泊洛沙坶407)=5 mg·ml^(-1)),0.385 mg·ml^(-1)(CSDS=10 mg·ml^(-1)),0.309 mg·ml^(-1)(C_(PVPK30)=10 mg·ml^(-1)),0.340 mg·ml^(-1)(C_(HPMC K100)=5 mg·ml^(-1)),0.401 mg·ml^(-1)(C_(HPMC50)=5 mg·ml^(-1)),0.426 mg·ml^(-1)(C_(HPMC K30)=10 mg·ml^(-1))。在高温灭菌和低温冷藏后稳定性考察中,含有增溶剂的呋喃西林溶液的稳定性显著好于不含增溶剂的呋喃西林溶液。结论:在呋喃西林溶液中加入0.1%～0.5%的HPMC K100更为合理。

Objective：To study the effect of different solubility enhancers and polymers on the solubilization and solution stability of furacilin.Method：Furacilin solutions were prepared using various solubility enhancers and polymers with different concentrations, including sodium dodecyl sulfate（SDS）,Tween-80,poloxamer 407,PVP K30,HPMC K_（100）,HPMC 50 and HPMC 30.The maximum solubility was determined by UV spectrophotometry,and the furacilin solution stability was investigated under the conditions of high temperature sterilization and cold storage.Result：The maximum solubility of furacilin with the solubilizer concentration range of 0.1- 10.0 mg？ml^-1 was as follows：0.245 mg· ml^-1（C_（Tween80） =5 mg· ml^-1 ）,0.256 mg· ml^-1（C_（poloxamer407） = 5 mg· ml^-1 ）,0.385 mg· ml^-1（C_（SDS） = 10 mg· ml^-1）,0.309 mg· ml^-1（C_（PVPK30）= 10 mg· ml^-1 ）,0.340 mg· ml^-1（C_（HPMC K_（100）） =5 mg· ml^-1 ）,0.401 mg· ml（C_（HPMC50） =5 mg· ml^-1） and 0.426 mg· ml^-1（C_（HPMC30） = 10 mg· ml^-1 ）.Furacilin solutions containing the solubilizer were more stable than furacilin solution without any solubilizer under the conditions of high temperature sterilization and cold storage.Conclusion： Water-soluble polymer HPMC K_（100） with the concentration of 0.1%-0.5%may be the most suitable solubilizer to furacilin solution.